The Effect of a Honey-based Gel Supplement From the Wider Area of Pindos on Human Health and Oxidative Stress Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in glutathione concentration of erythrocytes
研究概览
简要总结
The aim of the present clinical study is to estimate the efficacy of a honey-based gel, derived from the wider area of Pindos in Greece, in regulating oxidative stress biomarkers and the physiological profile of healthy adults.
详细描述
Introduction
Honey contains about 200 compounds such as sugars, proteins, vitamins, water, free amino acids, enzymes, minerals, and many phytochemicals. Due to its composition, enriched with many bioactive ingredients, several studies have established its antimicrobial, antiviral, anticancer, antidiabetic and antioxidant properties. This multilayer activity of honey has been proposed for the protection against pathologies interrelated with the cardiovascular, nervous, respiratory, and gastrointestinal system.
Purpose: This study aims to investigate the effects of a novel natural honey-based gel consumption on oxidative stress biomarkers, blood chemistry and physiological characteristics in healthy individuals.
Methodology: A total of 20 healthy men and women will participate in the study. Participants will give their informed consent after they will be informed about the purposes, procedures, risks and benefits associated with the study. Participants will consume 70 g/day of the honey-based gel, distributed in 2 equal doses (in the morning and evening) for 14 days. At baseline and post-intervention, volunteers will be assessed for their physiological profile and will provide a resting blood sample for the assessment of oxidative stress and blood chemistry biomarkers as well as their physiological profile. Participants will be asked to record their diet for 3 days prior to the study and they will be asked to follow the same dietary pattern for 3 days before the post-intervention assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Individuals aged 18-65 years
- •Non-smokers
排除标准
- •Musculoskeletal injury
- •Dietary supplements
- •Medication
- •Allergy in bee pollen
结局指标
主要结局
Change in glutathione concentration of erythrocytes
时间窗: Change from baseline to 14 days
Glutathione concentration will be analyzed in erythrocytes by spectrophotometry
Change in total antioxidant capacity of plasma
时间窗: Change from baseline to 14 days
Total antioxidant capacity will be analyzed in plasma by spectrophotometry
Change in protein carbonyls of plasma
时间窗: Change from baseline to 14 days
Protein Carbonyls will be analyzed in plasma by spectrophotometry
Change in thiobarbituric acid reactive substances of plasma
时间窗: Change from baseline to 14 days
Thiobarbituric acid reactive substances will be analyzed in plasma by spectrophotometry
Change in body weight
时间窗: Change from baseline to 14 days
Body weight will be measured using a digital scale
Change in catalase enzyme activity of erythrocytes
时间窗: Change from baseline to 14 days
Catalase enzyme activity will be analyzed in erythrocytes by spectrophotometry
Change in complete blood count
时间窗: Change from baseline to 14 days
White blood cells, lymphocytes, monocytes, granulocytes, red blood cells and platelets will be analyzed in whole blood
Change in body fat
时间窗: Change from baseline to 14 days
Body fat will be measured by bioelectrical impedance analysis
Change in diastolic and systolic blood pressure
时间窗: Change from baseline to 14 days
Diastolic and systolic blood pressure will be measured using a manual sphygmomanometer
Change in waist and hip circumference
时间窗: Change from baseline to 14 days
Waist and hip circumference will be assessed using a tape measure
Change in resting heart rate
时间窗: Change from baseline to 14 days
Resting heart rate will be measured using a heart rate sensor
次要结局
未报告次要终点
研究者
Athanasios Z. Jamurtas
Professor
University of Thessaly